The SARS-CoV-2 Antibody Assay Monitoring (SAAM) program was initiated in the Fall of 2020 in response to the urgent need to develop safe and effective vaccines and immunotherapeutics for SARS-CoV-2, the etiologic agent of COVID-19. The SAAM program includes two components aimed at providing support for laboratories that are performing clinical endpoint assays for Phase 3 clinical trials in support of the US Government Countermeasures Acceleration Group (CAG). The first component is the SAAM External Quality Assurance (EQA) program, designed to assess assay proficiency across all labs. The second component is the Internal Quality Control (IQC) program which is designed to track the internal control material that is tested alongside the clinical trial material.
Participation is required for labs that are performing primary immune assays to evaluate binding and neutralizing antibodies elicited from vaccines in Phase 3 clinical trials testing that were developed with USG funding. Participating laboratories are the same across the EQA and IQC programs.
The EQAPOL SAAM EQA Program is accredited to the International Organization for Standardization/ International Electrotechnical Commission (ISO/IEC) 17043:2010 standards by the American Association for Laboratory Accreditation (A2LA).
Once available, site reports for EQAPOL SAAM can be accessed using the EQAPOL web-based application (https://eqapolapp.dhvi.duke.edu).